Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in France / NCT06283797
Recruiting Not applicable

Efficacy of Automated Insulin Therapy Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes

NCT06283797 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Montpellier
Phase
Not applicable
Started
2024-05-29
Last updated
2025-04-06

Condition(s) studied

Diabetes

Investigational drug(s) / intervention(s)

OmniPod 5Dexcom G6PAID questionnaires

OmniPod 5: Participants will be trained to use OmniPod 5 to treat type 1 diabetes for 1 year

Dexcom G6: Participants will use Dexcom G6 for continuous glucose monitoring

PAID questionnaires: At visits 3, 7 and 11, parents/guardians and patients aged between 8 and 17 will complete diabetes-related problem questionnaires (PAID-PR, PAID-Peds)

Study summary

The main objective is to assess whether hybrid closed-loop (HCL) insulin delivery initiated early after diagnosis of Type 1 diabetes (T1D) allows a better efficacy on glucose control than conventional standard insulin therapy with multiple daily insulin injections (MDI) or insulin pumps after one year of use.

The secondary objectives are to assess whether HCL initiated early after diagnosis of T1D allows: (1) Higher time spent with glucose level in the near-normal range, (2) Lower time spent in hypoglycemia and hyperglycemia, (3) Lower glucose variability, (4) Lower perceived burden of diabetes management, (5) Better preserved endogenous insulin secretion, all the above after one year of use, (6) Lower occurrence of interventions for hypoglycemia, versus conventional standard insulin therapy with MDI or insulin pump.

An optional 1-year extension aims at assessing: (1) Sustainability of above mentioned parameters over a second year of HCL use in the group who started HCL early after diagnosis, (2) Efficacy on glucose control according to the above mentioned parameters when HCL is initiated early after diagnosis vs. after 1 year in the control group of the randomized phase.

Eligibility

Sex
ALL
Min age
2 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Aged between 2 and 17.9 years * Diagnosis of type 1 diabetes since at least 3 months and up to 6 months based upon WHO criteria * Identification of at least one positive plasma auto-antibody among anti-GAD, anti-IA2, anti-ZnT8 and anti-insulin * Treatment by multiple-daily insulin injections or insulin pump. An insulin pump with a function of stopping the pump in case of predicted hypoglycaemia is allowed. * Patient and/or parents/guardians trained in carbohydrate counting * Patient and/or parents/guardians must have a smartphone that supports the Dexcom G6 app download and participants must be willing to use Dexcom G6 sensor and app throughout the study Exclusion Criteria: * Unwillingness of one parent or the legally responsible party to participate in insulin treatment * Any associated chronic disease or therapy (except insulin or L thyroxin at stable dose) affecting glucose metabolism * Therapy by automated insulin delivery using an insulin pump connected to continuous glucose monitoring sensor with a control algorithm (hybrid closed-loop system) * Cutaneous allergy or contact dermatitis to device (CGM or pod) adhesives * Insufficient vision and/or hearing to recognise all the functions of the Omnipod 5 system, including alerts, alarms and reminders in accordance with the instructions of utilization * Impaired cognitive or psychological abilities of the patient and/or his/her parents or the legally responsible party which may result in defective adherence to study procedures * Active enrolment in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date * Subject who is in a dependency or employment with the sponsor or the investigator * No signed informed consent form by the patient and his/her parents/legally responsible party * Subjects unable to attend all scheduled visits and to comply with all trial procedures * Law protected or deprived of liberty subject * Pregnant and breastfeeding women * Subjects no covered by public health insurance

Primary outcome measure(s)

  • Glycated hemoglobin (HbA1c) level — At 1 year follow-up
    Change in the HbA1c level, measured by HPLC method, from the start of the randomized study phase to the end of this 1-year study phase

Trial sites (4)

FacilityCityRegionStatus
University Hospital, Angers Angers France Recruiting
University Hospital, Montpellier Montpellier France Recruiting
Robert Debré Hospital, AP-HP Paris France Recruiting
University Hospital, Tours Tours France Recruiting

More University Hospital, Montpellier trials in France

Neoadjuvant Atezo, Adjuvant Atezo + Beva Combined With RF Ablation of Small HCC: a Multicenter Randomized Phase II Trial Active, not recruiting
Persistence of Sensitization to Contrast Media Starting soon
Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI Starting soon
Validation of a Magnetic Sensor in Arterial Flow Recording, Compared With the Reference Method, at Various Peripheral Arterial Sites Recruiting
Is Trogocytosis a Predictive Marker of CAR-T Cell Response in Diffuse Large B-cell Lymphoma? Recruiting

Other trials for the same condition

Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease Recruiting
Implementation Trial In patieNts With rEnal failuRe and diAbetes for Major Adverse reNal and Cardiovascular Events Starting soon
Evaluation of Neurodevelopmental Trajectories in Children According to the Glycemic Profile Associated With Early Treatment Using an Automated Delivery System in Children With Type 1 Diabetes Recruiting
Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B) Recruiting
Prediction of Peripheral Neuropathy With Functional Testing Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06283797 on ClinicalTrials.gov ↗ ← All trials in France